Study Questions:

What is the impact of baseline activated clotting time (ACT)–guided heparin administration on major bleeding after transfemoral transcatheter aortic valve implantation (TAVI)?

Methods:

Of the patients who underwent transfemoral TAVI at San Raffaele Scientific Institute, Milan, Italy, from November 1, 2007 to June 31, 2012, 362 were retrospectively analyzed. Because abnormally high baseline ACT values were noted, heparin was administered at the operator’s discretion, according to baseline ACT (ACT guided, n = 174) or patient’s body weight (non–ACT-guided, n = 188). The primary study objective was 30-day major bleeding, as defined by the Valve Academic Research Consortium criteria. Secondary objectives were any life-threatening and minor bleeding, and other Valve Academic Research Consortium outcomes at 30 days.

Results:

Bleeding occurred in 167 (46.1%) patients; of these, 76 (21.0%) had major bleeding. The ACT-guided group had a significantly lower occurrence of major (7.5% vs. 33.5%, p < 0.001), life-threatening (12.1% vs. 20.2%, p = 0.04), and any bleeding (25.9% vs. 64.9%, p < 0.001). Conversely, no differences were noted in the other study objectives. After adjustment for potential confounders, the protective odds ratio for ACT-guided therapy on major bleeding was 6.4 (95% confidence interval, 2.3-17.9; p < 0.001) at 30 days.

Conclusions:

The authors concluded that heparin administration according to baseline ACT was correlated with a significantly lower occurrence of major bleeding in transfemoral TAVI.

Perspective:

This study reports that baseline ACT levels were generally elevated in patients with severe aortic stenosis, and compared with the non–ACT-guided strategy, baseline ACT-guided heparin administration during TAVI significantly reduced the occurrence of major bleeding, as well as any bleeding. Furthermore, ACT guidance was found to be an independent predictor of major bleeding events. These findings suggest that baseline ACT might be an effective tool in guiding heparin administration during transfemoral TAVI, and further studies are needed to confirm the usefulness of this strategy in reducing the bleeding in the TAVI study group.